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Sublimaze (Fentanyl Citrate) - Summary

 
 



SUBLIMAZE SUMMARY

SUBLIMAZE (fentanyl citrate) Injection is a potent narcotic analgesic. Each milliliter of solution contains fentanyl citrate equivalent to 50 mcg of fentanyl base, adjusted to pH 4.0 to 7.5 with sodium hydroxide.

SUBLIMAZE (fentanyl citrate) is indicated:

  • —for analgesic action of short duration during the anesthetic periods, premedication, induction and maintenance, and in the immediate postoperative period (recovery room) as the need arises.
  • —for use as a narcotic analgesic supplement in general or regional anesthesia.
  • —for administration with a neuroleptic as an anesthetic premedication, for the induction of anesthesia and as an adjunct in the maintenance of general and regional anesthesia.
  • —for use as an anesthetic agent with oxygen in selected high risk patients, such as those undergoing open heart surgery or certain complicated neurological or orthopedic procedures.

See all Sublimaze indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Sublimaze (Fentanyl)

Fentanyl Overdose Deaths Double in a Year
Source: MedicineNet alprazolam Specialty [2016.12.21]
Title: Fentanyl Overdose Deaths Double in a Year
Category: Health News
Created: 12/21/2016 12:00:00 AM
Last Editorial Review: 12/21/2016 12:00:00 AM

more news >>

Published Studies Related to Sublimaze (Fentanyl)

Efficacy and safety of sublingual fentanyl orally disintegrating tablet at doses determined from oral morphine rescue doses in the treatment of breakthrough cancer pain. [2015]
evaluate the efficacy and safety of sublingual fentanyl tablet... CONCLUSIONS: Patients treated with strong opioid analgesics at fixed intervals

Effect of intravenous fentanyl given prior to the end of surgery on emergence agitation in pediatric patients. [2013]
CONCLUSION: Administration of intravenous fentanyl 1 microg/kg 15 minutes prior

Desflurane/fentanyl compared with sevoflurane/fentanyl on awakening and quality of recovery in outpatient surgery using a laryngeal mask airway: a randomized, double-blinded controlled trial. [2013]
anesthetic regimen inclusive of opioids... CONCLUSIONS: Desflurane retains faster awakening properties than does sevoflurane

Clinical effects of intrathecal fentanyl on shoulder tip pain in laparoscopic total extraperitoneal inguinal hernia repair under spinal anaesthesia: a double-blind, prospective, randomized controlled trial. [2013]
anaesthesia... CONCLUSIONS: Addition of intrathecal fentanyl to local anaesthetic can relieve

A double-blinded randomized evaluation of alfentanil and morphine vs fentanyl: analgesia and sleep trial (DREAMFAST). [2013]
interference... CONCLUSIONS: Despite better early postoperative analgesia, pain-related sleep

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Clinical Trials Related to Sublimaze (Fentanyl)

Remifentanil vs Fentanyl During Cardiac Surgery and Chronic Thoracic Pain [Recruiting]
This study will investigate the influence of intra-operative use of remifentanil versus fentanyl on the percentage of patients with chronic thoracic after cardiac surgery via sternotomy. Secondary quantitative sensory testing is performed to determine thermal and electrical detection and pain threshold and the difference in pain variability scoring. Postoperative pain scores, analgesic use, genetic variances and costs are measured.

Procedural Pain Treatment With Transmucosal Sublingual Fentanyl Tablet in Colonoscopy Patients [Recruiting]
Colonoscopy is generally considered an invasive procedure that causes remarkable pain to the patient. The pain associated with the procedure is not caused by the insertion of the scope but from inflating of the colon in order to do the inspection. It has been shown that colonoscopy can be performed successfully without sedation (Leung, 2010), but many patients feel discomfort during the procedure. Factors predicting a painful colonoscopy are female-gender, degree of patient nervousness and the technical difficulty of the colonoscopy (Ylinen et al. 2009). Also age under 40, previous abdominal surgery and use of sedation are associated with painful colonoscopy ( Seip et al. 2009). Most often sedation and/or analgesia are achieved by administering a benzodiazepine or a combination of a benzodiazepine and an opioid (Fanti et al. 2009, Maskelar et al. 2009,), dexmedetomidine (Dere et al. 2009) or by using non-pharmacologic methods (Amer-Cuenca et al. 2011). Tramadol as monotherapy did not significantly decrease pain intensity or endoscopist's evaluation of colonoscopy (Grossi et al. 2004). Currently, intravenous midazolam is the drug used most commonly to introduce some sedation for colonoscopy. Intravenous sedation definitely increases the cost of procedure; drug administration, need for pulse oximetry monitoring and the need for follow-up after the procedure make colonoscopy sometimes expensive and troublesome. It has also been shown, that low-dose midazolam neither relieves discomfort nor makes patients forget it (Elphick et al. 2009). Fentanyl is a short-acting opioid widely used in anesthesia management. Transmucosal sublingual formulation of fentanyl has been developed to further improve the management of pain. When administered as a sublingual fast-dissolving tablet (Abstral®) that is placed under the tongue, the effects is fast and predictable. Its active ingredient is absorbed by the body through the mucous membrane. After administration of buccal fentanyl maximum plasma drug concentration was measured after 25 minutes (Darwish et al. 2011). Plasma fentanyl concentrations versus time following buccal and sublingual administration are very similar (Darwish et al. 2008). Abstral® sublingual tablets should be administered directly under the tongue at the deepest part. Sublingual administration is an easy and non-invasive method of pain treatment for the patient coming to colonoscopy done as an office based procedure. Other advantages compared to invasive methods are improved comfort of patients and no need for intravenous access because of pain relief. Before, it has been used in the management of breakthrough pain in cancer patients. Sublingual fentanyl is shown to be effective and well-tolerated for the treatment of breakthrough cancer pain (Uberall et al. 2011). The use of transmucosal tablet for colonoscopy patients is a quite new approach.

Fentanyl Effect on Blood Pressure in Elderly Patients After Induction of General Anesthesia [Recruiting]
Hypotension is frequently encountered after induction of general anesthesia. It can be pronounced in elderly patients and can require administration of vasopressor agents including ephedrine and phenylephrine. Intraoperative hypotension, especially prolonged episodes, can contribute to an increase in morbidity and mortality in the postoperative period as suggested by some former studies. The investigators hypothesize that fentanyl can contribute to the decrease in blood pressure (BP) that is seen after induction of general anesthesia in older patients. This hypotension may be due to fentanyl blocking effect on the sympathetic nervous system. This study will be the first one to examine the effect of fentanyl administration on blood pressure in elderly patients with induction of general anesthesia prior to the start of surgery. If the study shows that fentanyl contributes to hypotension during this period, it may lead to a change in practice and better patient outcomes and mortality rates.

Breakthrough Dyspnea Fentanyl Study in Cancer Patients [Completed]
The goal of this clinical research study is to learn if fentanyl given under the skin can reduce shortness of breath in cancer patients. Researchers also want to learn if it can help to improve your physical function. In this study, fentanyl will be compared to a placebo. Fentanyl is commonly used for treatment of cancer pain. It is believed to help patients with their shortness of breath as well. A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.

Comparison of Epidural Fentanyl and Clonidine for Breakthrough Pain [Recruiting]
Epidural analgesia has proven to be an effective method for severe pain relief associated with labor and delivery. During labor, a low dose continuous infusion of local anesthetic and narcotic will be administered through an epidural catheter. As labor progresses and the baby's head makes it way through the pelvis, breakthrough pain may emerge and often needs further treatment. The investigators provide pain relief by administering analgesics through the epidural catheter. The patient will be randomly assigned to receive one of two medication mixtures believed to be successful in treating this type of pain associated with advanced labor. After this initial treatment, if pain relief is not attained, the patient may receive the other medication as well. The medications used in this study have been used at this institution for some time and have been found to be safe for mother and baby. The opioid (fentanyl) dose is small and only a small fraction will be transmitted to the baby. The other medication (clonidine) better known as a blood pressure medication has also been used for pain relief. Studies and clinical experience have shown that clonidine when given epidurally in the doses used in this study has minimal if any effect on the blood pressure of the mother or of the baby. The investigators will record medical and obstetric history and labor progress relevant to the patient. The patient will be asked questions regarding labor pain and side effects before and after the analgesic is administered. The primary objective is to determine which treatment regimen is more successful in abolishing breakthrough pain in advanced labor.

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Page last updated: 2016-12-21

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